A Phase 4 interventional study of Povidone-iodine irrigation in Catheter; Infection (Indwelling Catheter), Catheter Infection and Catheter-Related Infections, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by William Beaumont Hospitals · Phase 4, Interventional, and Prevention
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Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of reasons, including monitoring of urine output in critically ill patients, relief of urinary obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% each day a catheter is left in place, meaning that by 30 days, generally 100% of patients with indwelling catheters will have bacteria in their urine. The majority of these people do not have urinary tract infections (UTIs), they are merely colonized and do not require treatment.
To define a standard (and ultimately to compare hospitals against each other), a surveillance definition for CAUTI has been developed by the National Healthcare Safety Network (NHSN). While useful for surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed as having a UTI). Despite continuing progress in standard methods of reducing infection rates (including decreasing the number of catheters inserted, ensuring proper catheter maintenance, and removing catheters when no long necessary) there continue to be unacceptably high rates of CAUTIs.
A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is preferable to an antibacterial for preventing further antimicrobial resistance development. Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of removal, is potentially preferable from the downstream standpoint of less antimicrobial resistance and reduced risk of Clostridium difficile infection.
2,094 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 3 is below the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal
Drug: Povidone-iodine irrigation
Catheter removal with no bladder irrigation
Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
Also known as: Betadine
Diagnosis of Urinary Tract Infection (UTI)
Per NHSN defined catheter associated UTI (CAUTI) criteria
Time frame: 48-72 hours after catheter removal
Diagnosis of UTI at 7 Days
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
Time frame: 7 days after catheter removal
Diagnosis of UTI at 28 Days
Per NHSN defined CAUTI criteria
Time frame: 28 days after catheter removal
Patients were recruited from the inpatient units of the hospital.
| Milestone | Povidone-Iodine Irrigation | Standard of Care |
|---|---|---|
| Started | 0 | 3 |
| Completed | 0 | 1 |
| Not completed | 0 | 2 |
Per NHSN defined catheter associated UTI (CAUTI) criteria
No measurements were reported for this outcome.
Per National Healthcare Safety Network (NHSN) defined CAUTI criteria
No measurements were reported for this outcome.
Per NHSN defined CAUTI criteria
No measurements were reported for this outcome.
Collected over 28 days; from study enrollment through the study completion. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Povidone-Iodine Irrigation | — | — | — |
| Standard of Care | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
No patients were randomized to the Povidone-Iodine arm
| Age, Categorical(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 3 | 3 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 3 | 3 |
| Race and Ethnicity Not Collected(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| United States | 0 | 3 | 3 |
| Presence of urinary tract infection(Participants) | Povidone-Iodine Irrigation | Standard of Care | Total |
|---|---|---|---|
| Count of participants | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Oct 2018, 6 months.
Results were first posted in Apr 2019, 6 months after primary completion.
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This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Povidone-Iodine